Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting
... cardiac symptoms or disease; and renal or
hepatic dysfunction. Edema, capillary leak syndrome, ... elevation of serum creatinine or bilirubin and
hepatic enzymes in some patients. Monitoring of renal and
hepatic function in patients with preexisting renal ...
New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure
... reactions that have occurred in adults.
hepatic Impairment
Thiazides should be used with caution in patients with impaired
hepatic function or progressive liver disease, since ... of fluid and electrolyte balance may precipitate
hepatic coma.
Hypersensitivity Reaction
...
New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure
... of the olmesartan medoxomil component.
hepatic Impairment
Since amlodipine is extensively ... is 56 hours in patients with severely impaired
hepatic function, caution should be exercised when administering AZOR to patients with severe
hepatic impairment.
Laboratory Tests
There was a ...
Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting
... bleeding, Child-Pugh class C, grade 2 or higher
hepatic encephalopathy, ascites requiring therapeutic ... significant reduction in clinical events of
hepatic decompensation on protocol-defined secondary ... of the product, autoimmune hepatitis, and
hepatic decompensation (Child-Pugh score greater than 6 ...
Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen
... any of its components, autoimmune hepatitis, and
hepatic decompensation (Child-Pugh score greater than 6; ... treatment. PEGASYS is also contraindicated in
hepatic decompensation with Child-Pugh score greater than ... C (CHC) patients with cirrhosis may be at risk of
hepatic decompensation and death when treated with alpha ...
Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C
... any of its components, autoimmune hepatitis, and
hepatic decompensation (Child-Pugh score greater than 6; ... treatment. PEGASYS is also contraindicated in
hepatic decompensation with Child-Pugh score greater than ... C (CHC) patients with cirrhosis may be at risk of
hepatic decompensation and death when treated with alpha ...
Dr. James F. Pingpank to Present at Leading Regional Therapies Conference
... company testing its proprietary Percutaneous
hepatic Perfusion ("PHP(TM)") System for the treatment of ... of High-dose Melphalan (MEL) Administered via
hepatic Arterial
Infusion for Patients with Unresectable
hepatic Metastases from
...
Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia
... taking dose. Use caution in patients with
hepatic impairment. ECGs should be obtained to monitor ... CYP3A4 inhibitors. Use caution in patients with
hepatic impairment. Obtain ECGs at baseline, seven days ... abnormality
Serum bilirubin and
hepatic transaminases
The use of Tasigna may result ...
More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies
... dose should be used for patients with severe
hepatic impairment. Patients with moderate renal ... taking dose. Use with caution in patients with
hepatic impairment. ECGs should be obtained to monitor ... CYP3A4 inhibitors. Use caution in patients with
hepatic impairment. Obtain ECGs at baseline, seven days ...
FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
... clinical symptoms of liver injury or evidence for
hepatic decompensation. Reinitiating treatment with ... when administering PROMACTA to patients with
hepatic disease. Use a lower starting dose of PROMACTA in patients with moderate to severe
hepatic disease and monitor closely.
Bone ...
Journal of Clinical Oncology Publishes Leukine(R) Study Demonstrating Positive Survival Outcomes in Patients with High-Risk Melanoma
... cardiac symptoms or disease; and renal or
hepatic dysfunction.
Edema, capillary leak syndrome, ... elevation of serum
creatinine or bilirubin and
hepatic enzymes in some patients. Monitoring of
renal and
hepatic function in patients with preexisting renal or ...
Study Supports Possible Use of Leukine(R) as a Potential Adjuvant Therapy for High-Risk Melanoma Patients
... cardiac symptoms or disease; and renal or
hepatic dysfunction.
Edema, capillary leak syndrome, ... elevation of serum
creatinine or bilirubin and
hepatic enzymes in some patients. Monitoring of
renal and
hepatic function in patients with preexisting renal or ...
CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI
... receiving allogeneic renal, cardiac or
hepatic transplants.
CellCept should be used ... count (ANC) cardiac, and up to 3.6% of
hepatic transplant patients receiving CellCept 3 g ... of renal, in 1.7% of cardiac, and in 5.4% of
hepatic transplant patients treated with CellCept 3 g ...
Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function
... receiving allogeneic renal, cardiac or
hepatic transplants.
CellCept should be used ... up to 2.8% of cardiac, and up to 3.6% of
hepatic transplant patients receiving CellCept 3 g ... of renal, in 1.7% of cardiac, and in 5.4% of
hepatic transplant patients treated with CellCept 3 g ...
Strength and Innovation of Novartis Oncology Products and Pipeline With Potential to Improve Patient Treatment Demonstrated by More Than 170 Abstracts at ASCO Annual Meeting
... taking dose. Use with caution in patients
with
hepatic impairment. ECGs should be obtained to monitor ... CYP3A4 inhibitors. Use
caution in patients with
hepatic impairment. Obtain ECGs at baseline, seven
days ... Liver function
abnormality Serum bilirubin and
hepatic transaminases: Tasigna may result
in elevations ...
New Data Shows 45 Percent of Patients with Stage 1 Hypertension Reached Normotension with BENICAR(R) and BENICAR HCT(R)
... adverse reactions that have occurred in adults.
hepatic Impairment
Thiazides should be used with ... of fluid and
electrolyte balance may precipitate
hepatic coma.
Hypersensitivity Reaction
... (creatinine clearance < 40 mL/min),
or in
hepatic dysfunction. In patients with possible depletion ...
Boehringer Ingelheim Initiates NEwArT Study Comparing Viramune(R) (nevirapine) to a Ritonavir-Boosted Atazanavir-based Regimen in Treatment-Naive HIV Patients
... VIRAMUNE. Any patient can experience
hepatic events; however,
female gender and higher CD4+ ... cells/mm3 unless
the benefit outweighs the risk.
hepatic events are often associated with
rash.
... Patients should be intensively monitored for
hepatic and skin reactions
for the first 18 weeks of ...
Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders
... aimed at developing new therapies for
hepatic disease." About GT4P GT4P is composed of a ... caution when administering to patients with
hepatic or renal
insufficiency. AMMONUL(R) may cause ... Use caution
when administering to patients with
hepatic or renal insufficiency or
inborn errors of beta ...
Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
... B or C co-infection or patients with mild
hepatic impairment.
-- Liver function tests should be ... for reports of: -- Clinical hepatitis and
hepatic decompensation including some fatalities. ... with reports of clinical hepatitis and
hepatic decompensation, including some fatalities. Extra ...
Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
... Doses to Subjects with Mild or
Moderate Chronic
hepatic Insufficiency" Cethromycin at 300 mg once daily for seven days was well tolerated by
subjects with
hepatic impairment and subjects with normal
hepatic function.
The results suggest that no dose ...
Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
... blood chemistry
tests to evaluate renal and
hepatic function. Dose adjustments to
pemetrexed and/or ... See also Warnings and Special Precautions.
hepatic impairment: Patients with
hepatic impairment, such as bilirubin
>1.5-times the ...
Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
... Doses to Subjects with Mild or
Moderate Chronic
hepatic Insufficiency" Cethromycin at 300 mg once daily for seven days was well tolerated by
subjects with
hepatic impairment and subjects with normal
hepatic function.
The results suggest that no dose ...
New Data From Large Safety Analysis of MYCAMINE Shows Favorable Clinical Safety Profile
... seen with analysis of adverse events. Shifts in
hepatic and
renal laboratory values during treatment with ... Isolated cases of clinically significant
hepatic dysfunction,
hepatitis, worsening
hepatic failure, renal dysfunction, acute renal
failure, ...
Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types
... taking Afinitor. Afinitor should not be used in patients with severe
hepatic impairment. Afinitor may cause fetal harm in pregnant women.
The most ... decrease in the recommended dose should be used for patients with severe
hepatic impairment.
Some GIST patients (5%) were reported to have severe ...
New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal
...
NUCYNTA(TM) is not recommended in patients with severe renal or
hepatic impairment. NUCYNTA(TM) should be used with caution in patients with moderate
hepatic impairment. Like other drugs with mu-opioid agonist activity, NUCYNTA(TM) ...
Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders
... retention with edema. Use caution when administering to patients with
hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or ... ongoing research and development of HPN-100 for urea cycle disorders,
hepatic encephalopathy, and other forms of hyperammonemia. Hyperion is ...
Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients
... alpha or any other component of the product, autoimmune hepatitis, and
hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in ... dyspnea, pulmonary infiltrates, pneumonia, interstitial pneumonitis,
hepatic failure, increases in serum creatinine in patients with renal ...
Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders
... ongoing research and development of HPN-100 for urea cycle disorders,
hepatic encephalopathy, and other forms of hyperammonemia.
About BUPHENYL(R) ... retention with edema. Use caution when administering to patients with
hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or ...
FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
... alpha or any other component of the product, autoimmune hepatitis, and
hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in ... dyspnea, pulmonary infiltrates, pneumonia, interstitial pneumonitis,
hepatic failure, increases in serum creatinine in patients with renal ...
FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
... caution in patients with pancreatic or biliary tract disease, and moderate
hepatic impairment. Because elderly patients are more likely to have decreased renal and
hepatic function, consideration should be given to starting elderly patients with ...
New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients
... to PEGASYS
or any of its components, autoimmune hepatitis, and
hepatic decompensation
(Child-Pugh score greater than 6; class B and C) in ... patients before or during treatment. PEGASYS is also
contraindicated in
hepatic decompensation with Child-Pugh score greater
than or equal to 6 in ...
GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition
... our medicine is very important to us. On a
continual basis, an external
hepatic Safety Board reviews any adverse event
report received by GSK of liver ... as July 2008,
this panel of experts continued to endorse a favorable
hepatic safety
profile for AVANDIA.
Patients being treated with AVANDIA or other ...
Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults
... have an increased
risk for liver function abnormalities, including severe
hepatic adverse
events.
Post-marketing cases of liver injury, including some ... are no pharmacokinetic or safety data available in
patients with severe
hepatic impairment.
PREZISTA should be used during pregnancy only if the ...
New Study Shows BENICAR(R) (olmesartan medoxomil) Reverses Blood Vessel Damage Independent of Blood Pressure Lowering
... and possibly
other adverse reactions that have occurred in adults.
hepatic Impairment
Thiazides should be used with caution in patients with ... since minor alterations of fluid and
electrolyte balance may precipitate
hepatic coma.
Hypersensitivity Reaction
Hypersensitivity reactions to ...
Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
... levels for the Phase
III clinical trial of the Company's Percutaneous
hepatic Perfusion (PHP)
technology for inoperable cancers in the liver. Enrollment ... an unprecedented
rate of response in this patient group, the median
hepatic progression free
survival was reported to be 39 months.
The presentation ...
PEGASYS(R)/COPEGUS(R) Show Benefit in Hard-to-Treat Latino Population with Hepatitis C
... to PEGASYS
or any of its components, autoimmune hepatitis, and
hepatic decompensation
(Child-Pugh score greater than 6; class B and C) in ... patients before or during treatment. PEGASYS is also
contraindicated in
hepatic decompensation with Child-Pugh score greater
than or equal to 6 in ...
Azor(TM) Reduces Blood Pressure in Difficult to Treat Special Populations
... be expected with AZOR because of the olmesartan
medoxomil component.
hepatic Impairment
Since amlodipine is extensively metabolized by the liver and ... should be exercised when administering AZOR to
patients with severe
hepatic impairment.
Laboratory Tests
There was a greater decrease in ...
Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)
... proposed by the Company has a
primary endpoint of a two-stage drop in
hepatic encephalopathy and its
secondary endpoints include several survival based endpoints. The Company
is refining its position that a two-stage drop in
hepatic encephalopathy is
clinically meaningful and an appropriate primary ...
Roche responds to announcement of 'IDEAL' hepatitis C trial results
... to PEGASYS
or any of its components, autoimmune hepatitis, and
hepatic decompensation
(Child-Pugh score greater than 6; class B and C) in ... patients before or during treatment. PEGASYS is also
contraindicated in
hepatic decompensation with Child-Pugh score greater
than or equal to 6 in ...
Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
... to
Vidaza or mannitol and in patients with advanced malignant
hepatic tumors.
In clinical studies, the most commonly occurring adverse ... Vidaza is potentially hepatotoxic in patients with severe
pre-existing
hepatic impairment, caution is needed in patients with liver
disease. In addition, ...